GITAM University Entrepreneurial Biotechnology
B.Tech. (BT) VII Semester
EURBT722: Departmental Elective: ENTREPRENEURAL
Course Code : EURBT 722 Category: DE
Credits: 3 Hours : 3 per week
Unit I: Project design. Market survey and assessment of demand for product.
Assessment of competing technologies for production. Evaluation of cost and
accessibility of raw materials, transportation, land, technology and HR inputs for
plant location. Plant design and economic assessment for variable product demand.
Environmental impact assessments.
Unit II: Intellectual Property: Concepts and Fundamentals
Mechanisms for protection of Intellectual Property- patents, copyright and trademark.
Protection of plant and animal genetic resources and other biological materials. Gene
patenting. Criteria for patentability. Types of patents. Protection for computer
databases and multimedia. Trademarks legislation and registration system. Trade
secrets: scope, modalities and protection.
Unit III: Technology Development/Transfer/Commercialization related aspects:
Biotechnology development. Toxicological studies, Bioequivalence (BU), Clinical
Trials-Phase 1,Phase II and Phase III. Approval Bodies and Agencies. Scale-up, semicommercialization
Unit IV: Managing technology transfer (TOT). Compulsory Licensing and access
to medicine issues. Drug Registration and Licensing Issues. Drug Master file
submissions, SOPS; Funding sources for commercialization of Technology:
Preparation of a project report, financial appraisal. Business models.
Unit V: Case studies: The foundation of Genentech. Brief discussion of Affymetrix
and Applied Biosystems. Brief descriptions of the products and infrastructure for top
10 biotechnology companies (Amgen, Genentech, Serono, Biogen-Idec, UCBCelltech,
Genzyme, Gilead, MedImmune, Chiron, Millennium). Brief description of
product portfolio of top ten biotechnology companies in India based on revenue in
2006 (Serum Institute of India, Biocon, Panaceae Biotech, Monsanto Biotech, Rasi
seeds, Venkateswara Hatcheries, Novo nordisk, Tulip, Indian immunologicals,
1. Building Biotechnology: Starting, Managing, and Understanding Biotechnology
Companies – Business Development, Entrepreneurship, Careers, Investing,
Science, Patents and Regulations by Yali Friedman 2nd ed. (2006) Thinkbiotech
2. Plant design and economics for chemical engineers. M.S.Peters and
K.D.Timmerhaus. 4th ed. McGraw Hill.
3. Dynamics of entrepreneurial development and management by V.Desai. (2006)
4. Biotechnology and Pharmaceutial Patents: Law and Practice by Marc S. Gross, S.
Peter Ludwig, Robert C., Jr. Sullivan